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15 August 2018
Proposed PMPRB amendments under consideration
Eight CSPs issued
Amended PMNOC Regulations
Cannabis Act passes
Consultation on national pharmacare
Damages and accounting references
Health Canada strengthens post-marketing oversight
This update outlines the major highlights in Canadian life sciences law over the past six months.
Consultation on the proposed Regulations Amending the Patented Medicines Regulations closed on 15 February 2018; consideration is ongoing (for further details please see "Canada releases proposed amendments to patented medicines pricing regulations"). Potential changes to pricing criteria include:
On 11 December 2017 the Patented Medicine Prices Review Board (PMPRB) released a scoping paper (for further details please see "PMPRB releases scoping paper concerning proposed amended regulations"). A steering committee will now consult on drafting new guidelines, expected to be released in Autumn 2018.(1) The proposed amendments contributed to Canada's appearance on the Office of the US Trade Representative's Priority Watch List.
Alexion's application for leave to appeal a decision dismissing its challenge to the constitutionality of certain PMPRB provisions of the Patent Act was dismissed on 28 June 2018.
Two other court cases are pending:
Certificates of supplementary protection (CSPs) provide an additional patent-like protection term and are intended to partly compensate the innovator for the time required for research and obtaining regulatory approval in Canada. Canada's regime came into force on September 2017 (for further details please see "Publication of final regulations on patent linkage and term restoration relating to CETA"). Eight CSPs have been issued to date.
Substantial amendments to the Patented Medicines (Notice of Compliance) (PMNOC) Regulations came into force on 21 September 2017, followed by the release of the Federal Court's practice notice (for further details please see "Health Canada and Federal Court publish guidance on final regulations on patent linkage and term restoration"). In March 2018 two procedural decisions were issued, finding that:
On 11 May 2018 Health Canada issued updated guidance, including Patent Register eligibility of CSPs. To date, approximately 21 actions (regarding 14 products) have been started and 11 trials have been scheduled.
There have been a number of new biosimilar approvals (there are now 11 in total), ongoing litigation matters, the publication of the Canadian Agency for Drugs and Technologies in Health's (CADTH's) Environmental Scan and aligned reviews between Health Canada and health technology assessment organisations (for further details please see "Mid-year biosimilars update").
Further, there was a consultation on naming and CADTH revised its biosimilar review process (for further details please see "CADTH outlines revisions to biosimilar and pharmaceutical review programmes").
Finally, on 7 March 2018 the Federal Court found in Hospira v Kennedy Trust and Janssen ( FC 259) that a patent for a use of infliximab (Janssen's REMICADE) in combination with methotrexate for the treatment of rheumatoid arthritis was valid and infringed by Hospira's biosimilar INFLECTRA (for further details please see "New use patent valid and infringed by biosimilar"). Hospira's appeal is pending.
On 21 June 2018 Bill C-45, the Cannabis Act, received royal assent, and adult use cannabis will be legal in Canada as of 21 October 2018. Final regulations to the Cannabis Act are expected soon, and are likely to be similar to the proposals set out in the Proposed Approach to the Regulation of Cannabis: Summary of Comments Received During the Public Consultation (for further details please see "Health Canada reports on consultation on proposed approach to cannabis regulation").
On 27 February 2018 the creation of an Advisory Council on the Implementation of National Pharmacare was announced (for further details please see "Federal Budget 2018 announces advisory council for national pharmacare programme"). On 19 April 2018 the Standing Committee on Health released a report advocating a national pharmacare programme – a single-payer, universal, publicly funded prescription drug coverage programme for all Canadians (for further details please see "Proposed national pharmacare programme and prescription and generic drug pricing modifications"). On 20 June 2018 the council was launched, alongside the release of a discussion paper and the opening of a public consultation.
On 15 February 2018 in Apotex v AstraZeneca ( FC 181) AstraZeneca was found not liable to Apotex for any Section 8 damages relating to its esomeprazole magnesium product (a generic version of AstraZeneca's NEXIUM), as Apotex's claim would be fully offset by its liability for patent infringement in the but-for world (for further details please see "No Section 8 liability for valid and infringed patent in Nexium proceeding"). The court separately held that AstraZeneca was entitled to a declaration of infringement in AstraZeneca's infringement action, following the Supreme Court of Canada decision striking down the promise doctrine (for further details please see "Promise doctrine struck down and AstraZeneca's NEXIUM patent upheld as useful"), and in doing so, rejected Apotex's attempts to raise new grounds of invalidity.
On 20 March 2018 the Federal Court of Appeal dismissed Eli Lilly's appeal of a decision awarding C$70 million in Section 8 damages to Teva relating to its lost olanzapine sales (a generic version of Eli Lilly's ZYPREXA), but granted Teva's cross-appeal seeking lost pipefill sales and an adjustment for under-reporting of sales (for further details please see "Court dismisses Section 8 damages appeal and grants cross-appeal"). Eli Lilly has sought leave to appeal (for further details please see "Eli Lilly seeks leave in olanzapine Section 8 damages action").
Finally, on 25 April 2018 the Quebec Superior Court in Apotex v Pfizer ( QCCS 1765) declined to dismiss Apotex's claim under the Ontario Statute of Monopolies relating to amlodipine besylate (Pfizer's NORVASC), finding it has jurisdiction (for further details please see "Quebec court declines to dismiss claim under Ontario Statute of Monopolies").
On 8 February 2018 the Federal Court of Appeal in Teva v Janssen ( FCA 33) dismissed Teva's appeal relating to Janssen's damages (C$19 million) for infringement of Janssen's patent for levofloxacin (LEVAQUIN), including affirming that Janssen had standing to make a claim (ie, it was not required to demonstrate that it had engaged in conduct in Canada that would otherwise amount to infringement) (for further details please see "Federal Court of Appeal dismisses Teva's levofloxacin damages appeal"). Teva has sought leave to appeal (for further details please see "Teva seeks leave in levofloxacin damages assessment").
On 28 March 2018 in ADIR and Servier v Apotex ( FC 346) Servier and ADIR were successful in the redetermination of the profits reference relating to perindopril (Servier's COVERSYL). The Federal Court again dismissed Apotex's non-infringing alternative defence, finding that Apotex would not have called on foreign third parties to manufacture perindopril to supply Apotex affiliates in the United Kingdom and Australia (for further details please see "Apotex fails to establish that it would have obtained non-infringing product from foreign suppliers"). The original C$61 million profits award against Apotex was therefore re-affirmed. Apotex has appealed.
Finally, the Federal Court of Appeal confirmed in Apotex v Bayer ( FCA 32) that an infringer does not have the right to elect a patentee's remedy.
The Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), which was approved on 6 November 2014, amended the Food and Drugs Act and granted the minister of health new post-marketing oversight powers over therapeutic products.
The developments to date include:
Other new guidance documents include:
For further information on this topic please contact Nancy Pei at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (email@example.com). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
(1) See 25 June 2018 guidance document.
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